A RANDOMIZED TRIAL OF ASPIRIN AND BETA-CAROTENE IN U S M

USM 中阿司匹林和 β-胡萝卜素的随机试验

• 批准号: 3180210
• 负责人: Julie E. Buring
• 金额: $ 96.63万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1984
• 资助国家: 美国
• 起止时间: 1984-12-01 至 1991-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3180210
• 关键词: Lyme disease; aspirin; atherosclerosis; cancer prevention; cardiovascular disorder epidemiology; cardiovascular disorder prevention; carotene; coronary disorder; human middle age (35-64); human subject; human therapy evaluation; male; physicians; placebos; therapy compliance; Lyme disease; aspirin; atherosclerosis; cancer prevention; cardiovascular disorder epidemiology; cardiovascular disorder prevention; carotene; coronary disorder; human middle age (35-64); human subject; human therapy evaluation; male; physicians; placebos; therapy compliance

We propose to conduct a five-year randomized, double-blind, placebo-controlled trial of the effect of alternate-day consumption of a ewt mg aspirin tablet primarily on cardiovascular mortality (but also on total mortality) among male U.S. physicians, 50 to 75 years of age. We mailed study materials to a random sample of 5000 subjects, and their replies indicated that we will enroll 21,900 apparently healthy men. Physicians who are eligible and willing to participate will be assigned at random to taking either a single 325 mg aspirin tablet or placebo every other day. Every six months participants will be sent new supplies in monthly calendar packs and follow-up questionnaires asking about their compliance and recent health. Deaths in all randomized subjects will be documented by death certificates. Under the null hypothesis we would expect about 500 cardiovascular deaths and over 1000 total deaths in each group during the 4 1/2 years of data collection. A Mantel-Haenszel pooled analysis of all trials completed to date, including AMIS, indicate approximately a 20% reduction in reinfarction (95% confidence limits +11% to -28%) and approximately a 9% reduction in total mortality (-4% to +18%). (Repeating this analysis using the AMIS values adjusted by the Cox procedure gives reductions of 24% in reinfarction and 13% in total mortality, both significant). Thus, under reasonable alternative hypotheses (ie, a 20% reduction due to aspirin), this trial will have power greater than 90%. A subsidiary aim will be to assess the effect of ingestion of beta-carotene on the risk of developing cancer in this same population. To do this, we will randomly assign half of each aspirin/placebo treatment group to taking one 30 mg capsule of either beta-carotene of its placebo every other day. Our pilot study results and our consideration of possible interactions indicate that we can accomplish this important scientific objective without affecting the sensitivity (or the cost) of the aspirin component. The study will thus be a 2x2 factorial in which each participant takes a single tablet or capsule daily.

我们建议进行五年的随机，双盲， 安慰剂对照试验的替代消费的影响 EWT MG阿司匹林片主要在心血管死亡率上 美国男性医生的总死亡率），50至75岁。 我们 邮寄学习材料的随机样本，由5000名受试者及其 答复表明，我们将注册21,900名显然健康的男性。 符合条件并愿意参加的医师将被分配 随机服用单个325 mg阿司匹林片剂或安慰剂 前几天。 每六个月，参与者将收到新的用品 每月日历包和后续问卷询问他们 合规性和最近的健康状况。 所有随机受试者的死亡将是 由死亡证明书记录。 在零假设下，我们将 预计大约500例心血管死亡，每人超过1000多人 在4 1/2年收集数据中的组。 壁炉架 - 堆积 对包括AMI在内的所有完成的试验的分析表明 重新灌溉降低约20％（95％的置信度限制 +11％ 至-28％），总死亡率降低了约9％（-4％ +18％）。 （使用COX调整的AMIS值重复此分析 程序将减少24％的重新孔，总计13％ 死亡率，都有意义）。 因此，在合理的选择下 假设（即由于阿司匹林降低20％），该试验将具有权力 大于90％。 子公司的目标是评估摄入β-胡萝卜素的影响 在同一人群中患癌症的风险。 为此，我们 将随机分配每个阿司匹林/安慰剂治疗组的一半 每隔一天，其安慰剂的β-胡萝卜素的一个30 mg胶囊。 我们的试点研究结果以及我们对可能相互作用的考虑 表明我们可以实现这个重要的科学目标 影响阿司匹林成分的灵敏度（或成本）。 这 因此，研究将是一个2x2阶乘，每个参与者都需要一个 平板电脑或胶囊每天。